MalfunctionIOY
SUPPORT ARM 177
Received Dec 19, 2016
Report 8010042-2016-00576 · MDR key 6185735
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
WHILE REQUESTING FURTHER INFORMATION ABOUT THE SUPPORT ARM IT WAS CONCLUDED THAT THERE WAS NO FAULT WITH THE SUPPORT ARM. THE CUSTOMER HAD REQUEST TO ADD A SUPPORT ARM TO THE VENTILATOR SINCE THE VENTILATOR NOT WAS EQUIPPED WITH A SUPPORT ARM. THERE WAS NO PRODUCT MALFUNCTION AND THEREFORE NO INVESTIGATION IS PERFORMED.
Description of Event or Problem
(B)(4).
Description of Event or Problem
IT WAS REPORTED THAT THE SUPPORT ARM WAS REPLACED. NO PATIENT INVOLVEMENT REPORTED. (B)(4).